li>Write, review, and/or edit clinical regulatory documents such as CTD Module 2 summaries and Clinical Overviews, Clinical study reports (CSRs), and other regulatory documents, as needed (e.g., Responses to Health Authority questions, Briefing Books, 120-day Safety updates, Pediatric Investigational Plans, or Investigator Brochures.
Contribute scientifically and strategically to submission teams at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing (e.g., provide content expertise and guidance on regulatory requirements).